US: FDA warns on statin drugs

xinhuanet.com

The U.S. Food and Drug Administration has for the first time officially linked statin use with cognitive problems, media reported Wednesday.

Statins, the cholesterol-reducing medications, may cause memory loss, diabetes and muscle pain, the U.S. Federal health officials warned Tuesday.

The FDA planned to require drug makers to add the diabetes-risk language to the "warnings and precautions" section of the labels on statin drugs.

The drugs are usually used to prevent heart disease and they are among the most widely prescribed drugs in the world. Among the drugs involved are huge sellers like Lipitor, Zocor, Crestor and Vytorin.

The new alerts about risks provided more reasons that otherwise healthy people with moderately high cholesterol levels “should not be taking these drugs,” said Dr. Sidney M. Wolfe, director of Public Citizen’s health research group.

But the warning was not expected to prompt doctors to stop prescribing statins for patients with multiple risk factors for heart attack because cardiologists believe the benefits of statins still outweigh these risks for many patients.

“These are not major issues, and they really do not alter the decision-making process with regard to statins,” said Steven Nissen, chairman of cardiovascular medicine at the Cleveland Clinic.

The “cognitive changes can be quite dramatic” and “sustained” but that they disappear when statin therapy is stopped, said Amy Egan, the FDA's deputy director for safety of metabolic and endocrinological products

“We are trying to be as transparent as possible with our alerts and labeling,” said Dr. Egan, even though the alert on the possibility of fuzzy thinking “is not overly helpful.”